Using NIRS to improve outcomes in high-risk patients undergoing major surgery
BRAIN-targeted Goal-directed Therapy in High-risk Patients undeRgOing Major electIve SurgEry: the BRAIN-PROMISE Study
This study is testing if using a special non-invasive monitoring tool during surgery can help high-risk elderly or frail patients have fewer complications after their operations compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milan) |
| Trial ID | NCT04266574 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of non-invasive monitoring using Near Infrared Spectroscopy (NIRS) to reduce postoperative complications in high-risk patients undergoing elective surgery. It involves a randomized controlled trial design where hypertensive elderly or frail patients will be monitored with an rSO2-based hemodynamic optimization algorithm. The primary focus is on assessing the incidence of perioperative complications within 30 days post-surgery and the success rate of reversing reductions in NIRS measurements. The study will compare outcomes between patients receiving NIRS-targeted therapy and those receiving standard care.
Who should consider this trial
Good fit: Ideal candidates include hypertensive patients aged 65 and older or those with a frailty score of 5 or more, undergoing major elective surgery.
Not a fit: Patients who may not benefit include those unable to consent, those with severe neurological or psychiatric diseases, or those not on hypertensive medication.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for high-risk surgical patients.
How similar studies have performed: Other studies have shown promise in using NIRS for monitoring in surgical settings, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5 * presence of an arterial catheter during anesthesia * planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia * ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations Exclusion Criteria: * Unable to consent to study inclusion * Language barrier * Severe neurological or psychiatric disease * End-stage dementia * Total Intravenous anesthesia * No use of hypertensive medication at home.
Where this trial is running
Rozzano, Milan
- Humanitas Research Hospital — Rozzano, Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Maurizio Cecconi, Prof, MD — Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study coordinator: Maurizio Cecconi, Prof, MD
- Email: maurizio.cecconi@hunimed.eu
- Phone: 0282244115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.